Metabolic Effects of One-weak Heavy Drinking

Glucose Intolerance Clinical Trial

— ROSMET  

Official title:

Metabolic Effects of One-Week Heavy Drinking and Fast Food Intake During Roskilde Festival in Young Healthy Male Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04229550
• Other study ID #: H-15019685
• Status: Completed
• Phase: N/A
• Start date: June 1, 2016
• Est. completion date: July 4, 2016

Study information

• Verified date: January 2020
• Source: University Hospital, Gentofte, Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Examination of the effect of one week's unhealthy lifestyle on glucose metabolism and liver parameters in a group of young, healthy males participating in Roskilde Festival 2016.

Description:

Metabolic effects of intermittent unhealthy lifestyle in otherwise young healthy adults are poorly studied. The investigators evaluated the effect of one week's unhealthy lifestyle on glucose metabolism and liver parameters in a group of young, healthy males participating in Roskilde Festival 2016.

Festival participants were studied before and after participation (one week) in Roskilde Festival 2016 and matched with controls who lead a normal life for an equivalent period of time. An oral glucose tolerance test (OGTT), abdominal ultrasound and strain elastography for liver stiffness were performed together with a bioimpedance scan and cognitive tests.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: July 4, 2016
• Est. primary completion date: July 4, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 30 Years

Eligibility

Inclusion Criteria:

• BMI of 18,5-25 kg/m2

• Normal liver function (assessed by ASAT, ALAT, GGT, alkaline phosphatase, albumin and bilirubin, coagulation factors II, VII and X, INR and platelets)

Exclusion Criteria:

• Planning alcohol withdrawal or dieting/a special low-fat diet during Roskilde Festival

• Diabetes or pre-diabetes

• First degree relatives with diabetes

• Kidney disease (eGFT<60 ml/min and/or albuminuria)

• Chronic diseases (in addition to those already mentioned) that could affect participation in festival activities (concerts and parties)

• Any condition in which the investigator believed would make it impossible to participate

Related Conditions & MeSH terms

• Alcohol; Harmful Use
• Glucose Intolerance
• Metabolic Disturbance

Intervention

Behavioral:
• Festival participation
One week's participation in Roskilde Festival 2016 or living a normal daily life.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Gentofte, Copenhagen

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Altered cognitive function	Evaluated by validated cognitive test ("SCIP")	First day after intervention week
Primary	Impairment of glucose tolerance	Evaluated by OGTT	First day after intervention week
Secondary	Hepatic steatosis	Evaluated by abdominal ultrasound scan	First day after intervention week